South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

Which act requires drugs to be proven safe before marketing?

1. Prescription Drug Marketing Act

2. Food, Drug, and Cosmetic Act

3. Kefauver-Harris Amendment

4. Drug Enforcement Administration Act

The correct answer is: Food, Drug, and Cosmetic Act

The Food, Drug, and Cosmetic Act is the foundational legislation that mandates the safety of drugs prior to their marketing. Enacted in 1938, this act was a major advancement in drug regulation, requiring that new drugs be proven safe for use before they could be sold to the public. This requirement was introduced in response to the tragic incidents caused by unsafe drugs in the years leading up to the act, highlighting the need for rigorous testing and oversight to protect public health. This act also established the framework for the FDA's authority to oversee the safety of food, drugs, and cosmetics, emphasizing the importance of ensuring that products are not only safe but also effective. It set the standards for pre-market approval, testing protocols, and the necessity of comprehensive data submission for evaluating a drug's safety profile. The other acts listed address different aspects of drug regulation. The Prescription Drug Marketing Act focuses primarily on the promotion and marketing of prescription drugs, while the Kefauver-Harris Amendment strengthens the safety and efficacy requirements established by the Food, Drug, and Cosmetic Act, requiring drug manufacturers to provide proof of the drug's efficacy as well. The Drug Enforcement Administration Act, on the other hand, pertains to the regulation of controlled substances and does not directly address the safety